FDA Updates Pregnancy Information on Interferon-β Drug Labels

Megan Brooks

April 06, 2020

The US Food and Drug Administration (FDA) has updated the prescribing information for peginterferon β-1a (Plegridy, Biogen) and interferon β-1a (Avonex, Biogen) regarding use during pregnancy in women with relapsing multiple sclerosis (MS).

The labels for Plegridy and Avonex previously stated that there are no adequate and well-controlled studies in pregnant women and noted that these drugs should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The updated labels now state that data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon-beta products during early pregnancy.

"The updated labels provide healthcare providers with additional data to inform treatment decisions for women who may be pregnant or planning for pregnancy. Previously there was not adequate data and patients were advised against using these products during pregnancy," Biogen said in email sent to Medscape Medical News.

"Patients are still advised to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant," Biogen said.

"Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy," Bernd Kieseier, MD, Biogen executive director, head of global MS, worldwide medical, added in a separate statement.

The updated labels for Plegridy and Avonex are available online.

Last year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended updating the label of approved interferon-β products to allow use during pregnancy and breastfeeding in women with relapsing MS, as reported by Medscape Medical News.

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